Tuyo Health, Inc. dba Tuyo Health
FDA issued a warning letter to Tuyo Health, Inc. (Miami, FL) in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro). Because compounded drugs are not FDA-approved, these claims rendered the products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Same active ingredient as Zepbound and Mounjaro
With compounded semaglutide, you get the same trusted active ingredient as in brand-name medications….
Same active as Wegovy and Ozempic
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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